InDevR Launches Potency Test Kit for Pandemic Flu Vaccines

To enable a rapid vaccine response during a severe outbreak or pandemic, there is a pressing need for a potency test that is rapid and has sufficient sensitivity to track potency in dose-sparing and adjuvanted vaccines.

InDevR has made available a new potency assay that enables rapid determination of immunogenic hemagglutinin in low-dose and adjuvanted flu vaccines, important in combating flu viruses with pandemic potential.

The panel of monoclonal antibodies that provide the test with virus subtype specificity were developed by scientists at the Center for Biologics Evaluation and Research (CBER) within the US Food and Drug Administration (FDA) and licensed by InDevR in 2017.

Avian influenza viruses, especially A/H5N1 and A/H7N9 viruses represent the latest threat for a lethal influenza pandemic. According to the December 2017 Risk Assessment Summary by the World Health Organization (WHO), “Since 2013, a total of 1565 laboratory-confirmed cases of human infection with avian influenza A(H7N9) viruses, including at least 612 deaths, have been reported to WHO.” In response to concerns over these deadly H7N9 flu viruses, in 2017 the US government issued a call for new vaccines to include in the Strategic National Stockpile for protection of the US population in the event of an outbreak.

The current gold standard method for flu vaccine potency determination, single radial immunodiffusion (SRID), can take months to develop the reference reagents needed to perform the SRID assay, which, as demonstrated in the 2009 H1N1 pandemic can delay the delivery of flu vaccine.

In contrast, the VaxArray® Pandemic Hemagglutinin Potency product is ready for use “off the shelf” and, subject to regulatory approval for lot release testing, could be implemented immediately for dose-sparing and/or adjuvanted vaccines if a new, responsive H5, H7, or H9 flu virus emerges as a threat.

This work was sponsored as part of the Department of Health and Human Services’ inter-agency Influenza Vaccine Improvement Initiative. Specifically, product development was supported by a Small Business Innovation Research grant R44AI102318 through the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health (NIH).